RecruitingPhase 3NCT07043725

A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer

A Randomized, Open-label, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus TCbHP in Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression

Sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Enrollment

544 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

HER2-positive Breast Cancer

Summary

This is a randomized, open, positive drug control, multi center phase III study. Through the evaluation of tpCR, bpCR, ORR, EFS, IDFS, OS , AEs and other indicators, it proves the effectiveness and safety of TQB2102 for injection versus TCbHP in the neoadjuvant treatment of HER2 positive breast cancer patients.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental drug called TQB2102 combined with standard chemotherapy (docetaxel and carboplatin, or paclitaxel and carboplatin) as pre-surgery (neoadjuvant) treatment for patients with HER2-positive breast cancer. HER2-positive means the cancer has high levels of a protein that makes it grow faster. The goal is to shrink the tumor before surgery and see how well this combination works. **You may be eligible if...** - You have been diagnosed with HER2-positive invasive breast cancer, confirmed by biopsy - Your cancer is at a stage that can be surgically removed (clinical stage T2-4 or any T with involved lymph nodes, M0) - You are in good physical condition (ECOG 0–1) with an expected survival over 6 months - Your organ function meets the required levels - You are willing to undergo surgery after completing neoadjuvant therapy **You may NOT be eligible if...** - You have already received treatment for this breast cancer - Your cancer has spread to distant organs - You have serious organ dysfunction or uncontrolled medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTQB2102 for injection

TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)

DRUGTrastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection

TCbHP is a commonly used chemotherapy scheme for HER2 positive breast cancer. H represents Trastuzumab injection, P represents Pertuzumab Injection, T represents Docetaxel injection and C represents Carboplatin injection.

Locations(78)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

The First Affiliated Hospital of Wannan Medical University

Wuhu, Anhui, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The Cancer Hospital Affiliated to Chongqing University, Chongqing Cancer Hospital, Chongqing Cancer Research Institute, and Chongqing Cancer Center

Chongqing, Chongqing Municipality, China

The First Hospital Affiliated to Army Medical University

Chongqing, Chongqing Municipality, China

Quanzhou First Hospital

Quanzhou, Fujian, China

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, China

Zhongshan Hospital Xiamen university

Xiamen, Fujian, China

ZhangZhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, China

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Gansu Provincial Academic Institute for Medical Research, Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China

Gansu Wuwei Tumour Hospital

Wuwei, Gansu, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Meizhou People's Hospital

Meizhou, Guangdong, China

Shantou Central Hospital

Shantou, Guangdong, China

Guigang City People's Hospital

Guigang, Guangxi, China

Guangxi Cancer Institutu (Guangxi Cancer Hospital, Guangxi Medical University Cancer Hospital, Guangxi Cancer Center)

Nanning, Guangxi, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

The Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Cangzhou Central Hospital

Cangzhou, Hebei, China

First Hospital of QinHuangDao

Qinhuangdao, Hebei, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Jiamusi Cancer Hospital

Jiamusi, Heilongjiang, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjinag, China

Anyang Tumor Hospital

Anyang, Henan, China

The People's Hospital of Anyang City

Anyang, Henan, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Xiangya Hospital Central South University

Changsha, Hunan, China

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

Xiangya Hospital ZhuZhou Central South University

Zhuzhou, Hunan, China

Chifeng Municipal Hospital

Chifeng, Inner Mongolia, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

NanChang People's Hospital

Nanchang, Jiangxi, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, China

Shengjing Hospital Of China Medical University

Shenyang, Liaoning, China

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

The First Affiliated Hospital of the Air Force Medical University of the People's Liberation Army

Xi'an, Shaanxi, China

The Second Affiliated Hospital of the Air Force Medical University of the People's Liberation Army

Xi'an, Shaanxi, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Cancer Hospital of Shandong First Medical University, Shandong Cancer Institute, Shandong Cancer Hospital

Jinan, Shandong, China

Linyi Cancer Hospital

Linyi, Shandong, China

The Second Affiliated Hospital of Shandong First Medical University

Taian, Shandong, China

WeiFang People's Hospital

Weifang, Shandong, China

Weihai Municipal Hospital

Weihai, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Zibo Central Hospital

Zibo, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Yuncheng Central Hospital

Yuncheng, Shanxi, China

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

The Second People's Hospital of YiBin

Yibin, Sichuan, China

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Xinjiang Medical University Cancer Hospital

Ürümqi, Xinjiang, China

Xinjiang Medical University Cancer Hospital

Ürümqi, Xinjiang, China

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Shaoxing People's Hospital

Shaoxing, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07043725

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